MDT · News · 20261106N

Regulatory Approval Milestones

Medtronic plc · 2026-11-06 · Importance 47 · Surprise 60

The FDA expanded the labeling for Medtronic's Symplicity Spyral renal denervation system, broadening its use in hypertension and adding clinical data for patients with isolated systolic hypertension, chronic kidney disease up to stage 3b, and type 2 diabetes. The change followed results from the SPYRAL AFFIRM post-approval study, which met its primary endpoint and showed statistically significant blood pressure reductions at six months across office, home, and 24-hour monitoring. The reported composite safety event rate was 2.1%, with no increase in antihypertensive medications.

Key facts

• The FDA approved expanded labeling for the Symplicity Spyral catheter to include additional clinical data in patients with isolated systolic hypertension, chronic kidney disease up to stage 3b, and type 2 diabetes. source